Radiation Therapy Following Surgery to Remove Brain Metastases
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy after surgery to remove brain metastases may decrease the amount of radiation required to treat brain metastases.
PURPOSE: Pilot trial to study the effectiveness of radiation therapy following surgery to remove brain metastases.
Procedure: surgical procedure
Radiation: radiation therapy
Radiation: stereotactic radiosurgery
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Pilot Study of Adjuvant Fractionated Stereotactic Radiotherapy Following Surgical Removal of Cerebral Metastases|
|Study Start Date:||March 1997|
|Primary Completion Date:||August 2006 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Assess the safety and tolerability of focal stereotactic radiotherapy to the surgical bed following excision of cerebral metastases, as an alternative to whole brain irradiation. II. Measure the local relapse rate at the surgical site after surgery and stereotactic radiotherapy in patients with cerebral metastases. III. Measure the regional relapse rate, in the brain but away from the treated site, following treatment in these patients.
OUTLINE: All patients undergo surgical removal of their cerebral metastases followed by adjuvant fractionated stereotactic radiotherapy daily for 5 days. Patients are given up to 5 weeks following surgery to recover and reach the required performance status. Radiotherapy must commence within 6 weeks of surgery. Patients are followed at 2 weeks after treatment, monthly for 6 months, every 3 months for the next 18 months, every 6 months for the next year, and then annually for years 3-5.
PROJECTED ACCRUAL: There will be 20-40 patients accrued into this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003320
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-1781|
|Study Chair:||Judith M. Ford, MD, PhD||Jonsson Comprehensive Cancer Center|